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# Sunovion Gets Rejection Letter on ADHD Drug
- URL: https://www.fdaweb.com/sunovion-gets-rejection-letter-on-adhd-drug/
- Published: 2018-08-31T12:00:00.000Z
- Updated: 2026-09-15T00:29:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142249

FDA has issued Sunovion Pharmaceuticals a complete response letter rejecting its NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention-deficit hyperactivity disorder. The letter asked for additional clinical data to further evaluate the drug’s efficacy and tolerability, according to the company. Sunovion says it plans to meet with FDA to discuss their comments and determine the next steps. Dasotraline is also being studied for treating moderate to severe binge eating disorder in adults. Data from two pivotal studies will support an NDA filing later this year.